EUCTR2011-000994-30-AT进行中（未招募）不适用
A randomized, double-blind, placebo controlled trial to evaluate the effects of vitamin D supplementation on metabolic and fertility parameters in PCOS women
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •PCOS women:
- •1) Premenopausal women =18 years
- •2) Polycystic ovary syndrome: 2 out of the following criterias are required:
- •a) Oligo- or anovulation
- •b) Biochemical and/or clinical hyperandrogenism
- •c) Polycystic ovaries
- •3) 25(OH)D <30 ng/ml
- •Healthy women:
- •1) Premenopausal women =18 years
- •2) Exclusion of Polycystic ovary syndrome
- •3) 25(OH)D <30 ng/ml
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •PCOS women:
- •Hypercalcemia
- •Withdrawn informed consent
- •Hormonal contraception in the last 3 months before entering the study
- •Insulin sensitizing agents in the last 6 months before entering the study
- •Lipid lowering agents and drugs affecting androgens and insulin sensitivity in the last 3 months before entering
- •Vitamin D supplementation in the last 3 months before entering the study
- •Hyperandrogenism caused by other diseases than polycystic ovary syndrome (Cushing disease, adrenogenital
- •Healthy women:
- •diagnosed PCOS or any of the following criteria:
- •Oligo- or anovulation, Biochemical and/or clinical hyperandrogenism, Polycystic ovaries
- •Hypercalcemia
- •Withdrawn informed consent
- •Hormonal contraception in the last 3 months before entering the study
- •Insulin sensitizing agents in the last 6 months before entering the study
- •Lipid lowering agents and drugs affecting androgens and insulin sensitivity in the last 3 months before entering
- •Vitamin D supplementation in the last 3 months before entering the study
研究者
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